APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults
Completed · Not applicable · Has a placebo group
Conditions studied: Foot Ulcer, Diabetic
In brief
This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.
Key facts
- Study ID
- NCT02356835
- Run by
- Origin Inc.
- People needed
- 10
- Starts
- 2015-02-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-03-17
Who can join
Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 19 to 80 years of age
- Type 1 or 2 diabetes with hemoglobin A1c less than 12%
- ABI ≥ 0.7, palpable pulses and/or biphasic waveform study with Doppler
- Wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)
You may not qualify if…
- Have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound
- Have a severe infection in the ulcer including the presence of an abscess, cellulitis extending > 2 cm beyond the ulcer margin, or osteomyelitis
- Have involvement of deeper tissues including bone or tendon
- Be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound
- Have received topical or systemic antimicrobial therapy within 48 hours of screening
- Have a malignancy other than skin cancer currently being treated
- Have substance abuse issues within the 6 months prior to screening
- Is a woman who is pregnant or breast feeding
- Has been treated with another investigational product within 30 days of screening
- Has been treated with tissue engineered skin or a biological therapy within 30 days of screening
Where it is running
- Baptist Health Institute for Advanced Wound Care — Montgomery, Alabama, United States
- Limb Preservation Platform, Inc. — Fresno, California, United States
- Limb Preservation Platform, Inc. — Fresno, California, United States
- New York College of Podiatric Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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